BioavailabilityBio-βNCT06214338
Blood Bioavailability of Two Different Doses of a β-alanine Supplement (BIo-β)
A study testing Low dose and High dose in people with Bioavailability, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
The purpose of this study is to To study the blood bioavailability of a sustained-release β-alanine granulated supplement of two different doses (10 g and 20 g). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Low dose and High dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 12 Feb 2024to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men between 18 and 60 years old.
- Cyclists with more than two years of cycling experience.
- Bicycle training at least twice a week.
Who cannot join
- Suffer a lasting injury that prevents you from training in the month prior to surgery.
- Subjects with a chronic illness.
- Having consumed in the three months prior to the start of the study any β-alanine supplement.
- Making changes in diet or exercise during the study.
- Inability to understand the informed consent form.
- Consumption of other supplements that could alter the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Bioavailability of Two Different Doses of a β-alanine Supplement
The purpose of this study is to To study the blood bioavailability of a sustained-release β-alanine granulated supplement of two different doses (10 g and 20 g).
Read the detailed description
Subjects will consume 10 g of β-alanine one day by 4 ingestions of 2.5 g separated by 1 hour and 15 min. While on another day 20 g of β-alanine by 4 ingestions of 5 g separated by 1 hour and 15 minutes, with a washout period of 15 days between the two doses. Subsequently, the amino acid levels in blood will be analyzed after the product intake and during a period of 8 hours.
Each day of visit the paresthesias (moment of appearance, intensity and sensations) will be studied at different times.
- Conditions
- Bioavailability
- Being tested
- Low dose, High dose
- Keywords
- β-alanine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low doseDietary supplement
Consumption of a β-alanine sustained-release supplement, 10 mg by 4 intakes of 2.5, separated by 1 hour and 15 min.
High doseDietary supplement
Consumption of a β-alanine sustained-release supplement, 10 mg by 4 intakes of 5 separated by 1 hour and 15 min.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | 10 mg of β-alanine Receives: Dietary Supplement: Low dose |
| High Dose | Experimental | 20 mg of β-alanine Receives: Dietary Supplement: High dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aminoacids in plasma
The complete series of amino acids will be analyzed in plasma, after supplement intake, for 8 hours and at various times after product intakes. A bioavailability curve will be developed for each of these samples.
Measured: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.
Secondary outcomes (2)
Paresthesia
It will be recorded by means of a visual analog scale (VAS), drawn with a continuous line of 10 centimeters where the left edge determines "no unusual sensation", translated to 0 in the recording of the data; and on the right edge "more intense sensation", translated to 10.
Measured: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.
symptomatology - qualitative question
They should answer if they have felt at any time after the ingestion of β-alanine any symptomatology such as: prickling, itching, tingling, numbness, chills and pain.
Measured: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start12 Feb 2024
- Primary completion18 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214338
- Sponsor's protocol ID
- UCAMCFE-00035
- Acronym
- Bio-β
- Status last verified
- Dec 2023
- First submitted
- 9 Jan 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Bioavailability of Two Different Doses of a β-alanine Supplement
- ClinicalTrials.gov ID
- NCT06214338
- Acronym / sponsor ID
- Bio-β / UCAMCFE-00035
- Conditions
- Bioavailability
- Keywords
- β-alanine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to To study the blood bioavailability of a sustained-release β-alanine granulated supplement of two different doses (10 g and 20 g).
Detailed description
Subjects will consume 10 g of β-alanine one day by 4 ingestions of 2.5 g separated by 1 hour and 15 min. While on another day 20 g of β-alanine by 4 ingestions of 5 g separated by 1 hour and 15 minutes, with a washout period of 15 days between the two doses. Subsequently, the amino acid levels in blood will be analyzed after the product intake and during a period of 8 hours.
Each day of visit the paresthesias (moment of appearance, intensity and sensations) will be studied at different times.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Dietary Supplement: Low dose10 mg of β-alanine |
| High Dose | Experimental | Dietary Supplement: High dose20 mg of β-alanine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men between 18 and 60 years old.
- Cyclists with more than two years of cycling experience.
- Bicycle training at least twice a week.
Key exclusion criteria (6 listed)
- Suffer a lasting injury that prevents you from training in the month prior to surgery.
- Subjects with a chronic illness.
- Having consumed in the three months prior to the start of the study any β-alanine supplement.
- Making changes in diet or exercise during the study.
- Inability to understand the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low doseConsumption of a β-alanine sustained-release supplement, 10 mg by 4 intakes of 2.5, separated by 1 hour and 15 min. | Dietary supplement | Low Dose |
| High doseConsumption of a β-alanine sustained-release supplement, 10 mg by 4 intakes of 5 separated by 1 hour and 15 min. | Dietary supplement | High Dose |
Primary outcome
Aminoacids in plasma
Time frame: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.
The complete series of amino acids will be analyzed in plasma, after supplement intake, for 8 hours and at various times after product intakes. A bioavailability curve will be developed for each of these samples.
2 secondary outcomes
Paresthesia
Time frame: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.
symptomatology - qualitative question
Time frame: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose and High dose in people with Bioavailability, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aminoacids in plasma (time frame: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.